A Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome

Acne Vulgaris Clinical Trial

Official title:

The Effects of a Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05271487
• Other study ID #: CB_Acne_01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2022
• Source: Integrative Skin Science and Research
• Contact: Jessica Maloh
• Phone: 9167502463
• Email: jessica[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyze changes in acne and changes in the gut and skin microbiome with the use of a multi-step botanical skin care regimen in those with mild to moderate acne.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• Subjects 15 years of age until 45 years of age.

• The presence of mild to moderate acne based on investigator global assessment.

Exclusion Criteria:

• The presence of severe acne as noted by the investigator global assessment.

• Those with a nut allergy.

• Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.

• Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.

• Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.

• Individuals who have been on an oral antibiotic for acne within the previous 1 month.

• Individuals who are pregnant or breastfeeding.

• Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.

• Oral supplementation that has nuts in it.

• Use of isotretinoin within the three months prior to joining the study.

• Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• Multi-Step Botanical Skin Care Regimen
The intervention includes 7 different topical products: Cleanser Toner Oil Control Cream Exfoliating Facial Scrub Clay Mask Acne Spot Treatment Body Scrub

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Codex Beauty Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total lesion count	Number of of inflammatory lesions, and open and closed comedones	8 weeks
Secondary	Inflammatory lesion count	Number of inflammatory lesions	4 weeks
Secondary	Inflammatory lesion count	Number of inflammatory lesions	8 weeks
Secondary	Non-inflammatory lesion count	Number of open and closed comedones	4 weeks
Secondary	Non-inflammatory lesion count	Number of open and closed comedones	8 weeks
Secondary	Investigator global assessment (IGA) of acne	Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne	4 weeks
Secondary	Investigator global assessment (IGA) of acne	Validated scale for global assessment of acne. Scale is 0 to 4 with 4 indicating greater severity of acne	8 weeks
Secondary	Sebum excretion	Measure of skin sebum via sebumeter	4 weeks
Secondary	Sebum excretion	Measure of skin sebum via sebumeter	8 weeks
Secondary	Gut microbiome assessment	Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample	4 weeks
Secondary	Gut microbiome assessment	Gut microbiome shift for short-chain fatty acid producing bacteria via stool sample	8 weeks
Secondary	Skin microbiome diversity	Shift in Shannon diversity of the skin microbiome	4 weeks
Secondary	Skin microbiome diversity	Shift in Shannon diversity of the skin microbiome	8 weeks
Secondary	Positive and Negative Affect Schedule (PANAS-SF)	Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect	4 weeks
Secondary	Positive and Negative Affect Schedule (PANAS-SF)	Survey assessing positive and negative mood states. Scores range from 10 to 50 with higher scores representing positive affect	8 weeks
Secondary	Diurnal Cortisol Slope	4 salivary cortisol collections to assess diurnal slope	4 weeks
Secondary	Diurnal Cortisol Slope	4 salivary cortisol collections to assess diurnal slope	8 weeks
Secondary	Salivary Sex Hormone Levels	1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS	4 weeks
Secondary	Salivary Sex Hormone Levels	1 salivary collection to assess estradiol, progesterone, testosterone, DHEAS	8 weeks